CN1436527A - Glimepiride dripping pills - Google Patents
Glimepiride dripping pills Download PDFInfo
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- CN1436527A CN1436527A CN 02110064 CN02110064A CN1436527A CN 1436527 A CN1436527 A CN 1436527A CN 02110064 CN02110064 CN 02110064 CN 02110064 A CN02110064 A CN 02110064A CN 1436527 A CN1436527 A CN 1436527A
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- glimepiride
- dripping pills
- dosage
- poloxamer
- macrogol
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Abstract
Glimepiride dripping pills contains Glimepiride 2-7 wt%, water soluble supplementary material polyglycol-4000 or polyglycol-1500 0-98 wt% and poloxame 0-50 wt%. The present invention is easy in regulating dosage and this is suitable for personal administration of diabetics in his initial stage and maintaining stage during long term treatment.
Description
The present invention relates to a kind of glimepiride dripping pills agent, belong to the Western medicine preparation technical field.
Glimepiride is a kind of new oral hypoglycemic medicine.Glimepiride is applicable to all unmanageable non-insulin-dependent diabetes mellitus of alimentary abstinence and physical training, still is applicable to single line treatment and the unique sulfonylureas that uses with insulin combination simultaneously.Common dosage forms is conventional tablet and the capsule of 1mg, 2mg, 3mg and 4mg clinically at present.This medicine (1) curative effect is strong, dosage is low; (2) drug treatment is long, and individual variation is big, and patient's dosage needs the 0.5-8mg various dose respectively in treatment and maintenance stage.Clinically, (1) occurs hypoglycemia when patient's blood sugar level is not high for after preventing to take medicine, and informal dress is with the dosage of 0.5mg; (2) when glimepiride and other medicines drug combination, the informal dress dosage of 0.5mg; (3) by when taking other medicines and change glimepiride into, take the dosage of 0.5mg at first.But, at present, the specification listing of 0.5mg dosage is not arranged as yet, and other dosage form is difficult to make the specification of 0.5mg.
The objective of the invention is at the problems referred to above, provide a kind of and can be used for oral drop pill easily, dosage is 0.5mg and 1mg.It can be according to the treatment needs, and the minimum dose of use acquisition blood glucose Satisfactory Control (general, the patient that diabetes are well controlled, every day, dosage was 0.5-4mg, a few patients dosage every day is greater than 6mg).
Technical characterstic of the present invention is: having selected for use water-soluble solid to disperse rerum natura pharmaceutic adjuvant Polyethylene Glycol and poloxamer is carrier, and medicine is dispersed in Polyethylene Glycol and the poloxamer, drips and makes ball.Glimepiride is the medicine of slightly solubility, and poloxamer plays the solubilizing agent effect in prescription, can improve the dissolubility of medicine.
Glimepiride dripping pills of the present invention is achieved in that its composition comprises glimepiride, water soluble adjuvant Macrogol 4000, polyethylene glycol 1500 and poloxamer, the percentage by weight of each composition is glimepiride 2-7, water soluble adjuvant Macrogol 4000 or Macrogol 1540 0-98 and poloxamer 0-50.
The preparation of glimepiride dripping pills agent of the present invention is with glimepiride crude drug and used adjuvant Polyethylene Glycol and poloxamer mixing, is heated to 75 ℃ and stirs, dissolves, splashes into curing in the liquid paraffin, filtration, drying, packing promptly.
This drop pill advantage is that (1) volume is little, taking convenience; (2) adjust dosage conveniently, especially be fit to period of disease and the individual administration scheme of keeping treatment in the diabetics long-term prescription process, avoided of the damage of the long-term excessive use of sulfonylureas simultaneously kidney.This product maximal dose is 8mg, and for producer, the drop pill of 0.5mg or 1mg can be applicable to all patients substantially, and the workshop of drop pill do not have dust, helps labor protection; Equipment is simple, and is easy to operate, and production process is few, and the cycle is short, the automaticity height.And working condition is easy to control, and the ball method of double differences is different little, and content is more accurate.
This product is 40 ℃ of temperature, under the condition of relative humidity 75%, and long term test six months, its content and dissolution result are as follows:
Glimepiride dripping pills accelerated test 6 months
Time (moon) dissolution (%) content (%)
0 91.85 107.60
1 91.49 105.14
2 92.85 107.49
3 93.78 107.02
6 93.72 106.55
Remarks: dissolution is according to dissolution determination method (two appendix X of Chinese Pharmacopoeia version in 2000 C three therapeutic methods of traditional Chinese medicine), with 0.02% tris solution 100ml is solvent, and rotating speed is that per minute 75 changes, operation in accordance with the law, sampling in 45 minutes, the mensuration wavelength is 229nm.
Assay is measured according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2000 D).The system suitability test is a filler with octadecylsilane chemically bonded silica; Methanol-0.01mol/L ammonium dihydrogen phosphate pH=3.5 (70: 30) is a mobile phase; The detection wavelength is 229nm.Press external standard method with calculated by peak area content.
By long term test 12 months as can be known, this product is stable.
The embodiment of the invention:
Example 1:
The glimepiride dripping pills prescription
Per 1000 consumptions of former, adjuvant title
Glimepiride 0.5g
Macrogol 4000 12.5mg
Poloxamer 2.5mg
The liquid paraffin condensing agent
Operating procedure
Glimepiride, Macrogol 4000 are put in the beaker, be heated to 75 ℃, stir, be uniformly dispersed, the dropper with φ 1mm splashes into mixed liquor in refrigerative liquid paraffin, and sedimentation was placed after 30 minutes, filtered, and dried, promptly.Every heavily about 15mg of ball contains glimepiride 0.5mg.
Example 2:
The glimepiride dripping pills prescription
Per 1000 consumptions of former, adjuvant title
Glimepiride 1g
Macrogol 4000 12mg
Polyethylene glycol 1500 12mg
Poloxamer 5mg
The liquid paraffin condensing agent
Operating procedure
Glimepiride, Macrogol 4000, Macrogol 1540 and poloxamer are put in the beaker, be heated to 75 ℃, stir, dissolve fully, with the dropper of φ 2mm, mixed liquor is splashed in refrigerative dimethicone, sedimentation was placed after 30 minutes, filter, dry, promptly.Every heavily about 30mg of ball contains glimepiride 1mg.
Claims (1)
1, a kind of glimepiride dripping pills agent, it is characterized in that comprising glimepiride, water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500 and poloxamer, the percentage by weight of each composition is glimepiride 2-7, water soluble adjuvant Macrogol 4000 or polyethylene glycol 1500 0-98 and poloxamer 0-50.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110064 CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02110064 CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1436527A true CN1436527A (en) | 2003-08-20 |
| CN1202816C CN1202816C (en) | 2005-05-25 |
Family
ID=27628156
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02110064 Expired - Lifetime CN1202816C (en) | 2002-02-07 | 2002-02-07 | Glimepiride dripping pills |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1202816C (en) |
Cited By (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1292736C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Dripping pill made from haw, chrysanthemum and Chinese wolfberry fruit and its preparing method |
| CN1292738C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method |
| CN1292739C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Shenerwuwei dripping pill for benefiting qi and nourishing yin and its preparing method |
| CN1292740C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and Chinese angelica root dripping pill and its preparing method |
| CN1292741C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and schisandra fruit dripping pill and its preparing method |
| CN1292737C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Oral administration dripping pill for nourishing heart to calm mind and its preparing method |
| CN1307980C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Lemai dripping pill for treating cardiovascular diseases and its preparing method |
| CN1307981C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Xuening dripping pill having hemostatic function and its preparing method |
| CN1307984C (en) * | 2005-03-28 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Cervix cancer drip pill and its preparation method |
| CN1307983C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Mai-an dripping pill for treating hyperlipoproteinemia and its preparing method |
| CN1307982C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Maishu dripping pill for reducing blood fat and its preparing method |
| CN1332651C (en) * | 2005-02-24 | 2007-08-22 | 北京正大绿洲医药科技有限公司 | Wuji dripping pill for treating liver and stomach diseases and its preparing method |
| CN104173308A (en) * | 2014-08-30 | 2014-12-03 | 山东新时代药业有限公司 | Glimepiride dropping pill |
-
2002
- 2002-02-07 CN CN 02110064 patent/CN1202816C/en not_active Expired - Lifetime
Cited By (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1292737C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Oral administration dripping pill for nourishing heart to calm mind and its preparing method |
| CN1292736C (en) * | 2005-02-18 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Dripping pill made from haw, chrysanthemum and Chinese wolfberry fruit and its preparing method |
| CN1332651C (en) * | 2005-02-24 | 2007-08-22 | 北京正大绿洲医药科技有限公司 | Wuji dripping pill for treating liver and stomach diseases and its preparing method |
| CN1292738C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng-pilose antler dripping pill for tonifying heart and kidney and its preparing method |
| CN1292739C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Shenerwuwei dripping pill for benefiting qi and nourishing yin and its preparing method |
| CN1292740C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and Chinese angelica root dripping pill and its preparing method |
| CN1292741C (en) * | 2005-02-24 | 2007-01-03 | 北京正大绿洲医药科技有限公司 | Ginseng and schisandra fruit dripping pill and its preparing method |
| CN1307980C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Lemai dripping pill for treating cardiovascular diseases and its preparing method |
| CN1307983C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Mai-an dripping pill for treating hyperlipoproteinemia and its preparing method |
| CN1307982C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Maishu dripping pill for reducing blood fat and its preparing method |
| CN1307981C (en) * | 2005-03-04 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Xuening dripping pill having hemostatic function and its preparing method |
| CN1307984C (en) * | 2005-03-28 | 2007-04-04 | 北京正大绿洲医药科技有限公司 | Cervix cancer drip pill and its preparation method |
| CN104173308A (en) * | 2014-08-30 | 2014-12-03 | 山东新时代药业有限公司 | Glimepiride dropping pill |
| CN104173308B (en) * | 2014-08-30 | 2017-03-22 | 山东新时代药业有限公司 | Glimepiride dropping pill |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1202816C (en) | 2005-05-25 |
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| C10 | Entry into substantive examination | ||
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| TR01 | Transfer of patent right |
Effective date of registration: 20160519 Address after: 273400 Shandong Feixian County North Ring Road No. 1 Patentee after: Shandong Xinshidai Pharmaceutical Industry Co., Ltd. Address before: 250100 Ji'nan Industrial Road, Shandong, No. 106 Patentee before: Wang Zhigang |
|
| CX01 | Expiry of patent term |
Granted publication date: 20050525 |
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| CX01 | Expiry of patent term |